His-Bundle Corrective Pacing in Heart Failure
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The investigators aim to prospectively evaluate the efficacy and mechanism of benefit of His-bundle pacing enhanced cardiac resynchronization therapy (His-CRT) vs. cardiac resynchronization therapy (BIV-CRT) in patients with heart failure and right bundle branch block (RBBB).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age 18 years or older (no upper age limit)
• Optimal medical therapy for heart failure by current guidelines
• Class IIa or IIb guideline-based indication for CRT-D implant in RBBB patients, including one of the following:
‣ New York Heart Association (NYHA) class II HF symptoms, LVEF ≤ 30% and QRS≥ 150 ms (IIb); OR
⁃ NYHA class III-IV a HF, LVEF ≤ 35%, and QRS duration ≥ 150 ms (IIa); OR
⁃ NYHA class III-IV a HF, LVEF ≤ 35%, and QRS duration 120-149 ms (IIb)
Locations
United States
Illinois
University of Chicago
RECRUITING
Chicago
New Jersey
Valley Health System
RECRUITING
Paramus
Vermont
University of Vermont
RECRUITING
Burlington
Contact Information
Primary
Ann Colasurdo
ann.colasurdo@heart.rochester.edu
585-275-1054
Backup
Mary Brown
mary.brown@heart.rochester.edu
585-273-5283
Time Frame
Start Date: 2022-12-02
Estimated Completion Date: 2027-07-01
Participants
Target number of participants: 120
Treatments
Active_comparator: His-CRT implantation
His-CRT implantation includes implantation of three leads, an endocardial right atrial lead, an endocardial right ventricular lead, and an endocardial His-bundle pacing leads directly pacing the intrinsic conduction system.
Active_comparator: BIV-CRT implantation
BIV-CRT implantation includes implantation of three leads, an endocardial right atrial lead, an endocardial right ventricular lead, and an epicardial left ventricular lead implanted in a branch of the coronary sinus.
Related Therapeutic Areas
Sponsors
Collaborators: National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
Leads: University of Rochester